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Selective Serotonin Reuptake Inhibitor

Escitalopram for Anxiety (PrEcISE Trial)

Phase 4
Recruiting
Led By Jeffrey R Strawn, MD
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
12 to 17 years of age, inclusive, at Visit 1.
Negative pregnancy test at Visit 1 in females
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12/early termination
Awards & highlights

PrEcISE Trial Summary

This trial will test whether a person's metabolism affects how they respond to the drug escitalopram. 132 people will be given the drug and monitored for 12 weeks.

Who is the study for?
This trial is for youths aged 12-17 with generalized, social, or separation anxiety disorder. They must have a certain severity of anxiety, no recent psychotherapy initiation, and be English-speaking. Participants need normal physical exams and EKGs, not be pregnant or drug-positive, and use reliable contraception if sexually active.Check my eligibility
What is being tested?
The study tests escitalopram dosing in anxious youth over 12 weeks. It's double-blind with participants randomly assigned to standard dosing or doses guided by their genetics. The randomization considers sex and how well their body processes drugs.See study design
What are the potential side effects?
Escitalopram may cause side effects like nausea, sleep issues (insomnia or excessive sleepiness), increased sweating, fatigue, dry mouth, sexual dysfunction and could increase the risk of suicidal thoughts especially in young people.

PrEcISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 17 years old.
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I have taken a pregnancy test and it was negative.
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I am between 12 and 17 years old.
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I have been diagnosed with anxiety disorder.
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My drug test at the first visit was negative.
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I am using or willing to use an approved method of birth control during the study.
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My physical exam and heart test results are normal.
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I haven't started new psychotherapy in the last 8 weeks and my current therapy has been stable for 2 months.
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I haven't started new psychotherapy in the last 8 weeks and my current therapy has been stable for 2 months.

PrEcISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12/early termination
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12/early termination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pediatric Anxiety Rating Scale severity score
Secondary outcome measures
Tolerability-Activation

Side effects data

From 2019 Phase 4 trial • 115 Patients • NCT01902004
23%
Sleepiness/Sedation
10%
Headache
8%
Tension/Inner Unrest
8%
Reduced Salivation
8%
Concentration Difficulties
8%
Diminished Sexual Drive
6%
Asthenia/Lassitude/Increased Fatigability
6%
Constipation
6%
Polyuria/Polydipsia
6%
Orthostatic Dizziness
4%
Nausea/Vomiting
4%
Erectile Dysfunction
4%
Failing Memory
2%
Diarrhea
2%
Increased Duration of Sleep
2%
Reduced Duration of Sleep
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Weight Gain
2%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine

PrEcISE Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard dosingExperimental Treatment1 Intervention
Patients randomized to standard dosing (std) will initiate escitalopram at 5 mg daily and will then increase to 20 mg/day at week 4.
Group II: Pharmacogenetically-guided escitalopram dosingExperimental Treatment1 Intervention
Patients randomized to PGx-guided treatment, escitalopram titration will be based on CYP2C19 phenotype and predicted escitalopram exposure. In poor metabolizers (PM), escitalopram will be initiated at 5 mg daily and increased to 10 mg daily at week 4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
2005
Completed Phase 4
~2330

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,660,348 Total Patients Enrolled
7 Trials studying Anxiety
4,714 Patients Enrolled for Anxiety
University of CincinnatiLead Sponsor
427 Previous Clinical Trials
634,239 Total Patients Enrolled
6 Trials studying Anxiety
696 Patients Enrolled for Anxiety
Jeffrey R Strawn, MDPrincipal InvestigatorUniversity of Cincinnati
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Anxiety
60 Patients Enrolled for Anxiety

Media Library

Escitalopram (Selective Serotonin Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04623099 — Phase 4
Anxiety Research Study Groups: Standard dosing, Pharmacogenetically-guided escitalopram dosing
Anxiety Clinical Trial 2023: Escitalopram Highlights & Side Effects. Trial Name: NCT04623099 — Phase 4
Escitalopram (Selective Serotonin Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04623099 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions within this investigation for participants?

"Affirmative. Clinicaltrials.gov indicates that the trial, which was initially advertised on March 8th 2021, is currently enrolling participants. 132 individuals from 1 clinical site are being sought for this research program."

Answered by AI

To what extent could Escitalopram be detrimental to individuals?

"Based on the Phase 4 status of Escitalopram, our team at Power assigned a score of 3 to its safety rating. This drug has already been approved for patient use."

Answered by AI

What is the upper limit of individuals participating in this clinical experiment?

"Affirmative. Clinicaltrials.gov informs that recruitment for this medical experiment is ongoing, commencing on the 8th of March 2021 and last updated on the 14th February 2022. In total, 132 individuals are required to participate at a single site."

Answered by AI

What qualifications do potential participants need to meet in order to be eligible for this experiment?

"This clinical trial calls for 132 participants, aged between 12 and 17 years old and suffering from an anxiety disorder."

Answered by AI

Are there any prior research studies that have explored the effects of Escitalopram?

"Presently, 23 different clinical trials are researching escitalopram with 5 of those in the final stages. Most of these tests take place in Cincinnati, Ohio though there are 45 distinct sites running this investigation."

Answered by AI

Does this trial encompass participants aged 85 and over?

"This study is open to adolescents aged 12-17. Clinicialtrials.gov has 148 trials recruiting for individuals under 18 and 453 studies looking for participants over 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
University of Cincinnati, Department of Psychiatry & Behavioral Neuroscience
What portion of applicants met pre-screening criteria?
Met criteria
~39 spots leftby Jun 2025